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Company · US

Dakocytomation California Inc

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2006. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)

13recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
NJT	Immunohistochemistry Reagents And Kits	11
MVC	System, Test, Her-2/Neu, Ihc	2
GKZ	Counter, Differential Cell	1
MXZ	Immunohistochemistry Assay, Antibody, Progesterone Receptor	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Aug 15, 2006	K060423	CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES Dakocytomation California, Inc.	GKZ
Feb 15, 2005	K042884	DAKOCYTOMATION ER/PR PHARMDX KIT Dakocytomation California, Inc.	MXZ

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4011 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4010 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4009 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4008 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4007 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4006 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4005 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4003 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4002 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4001 Terminated	NJT	None listed
Dec 23, 2005	Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000 Terminated	NJT	None listed
Nov 1, 2005	Dakocytomation California Inc K 520711-2, Hercep Test, 35Test, HER2, Protein Terminated	MVC	None listed
Nov 1, 2005	Dakocytomation California Inc K 520411-2, Hercep Test, 35Test, HER2, Protein Terminated	MVC	None listed

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